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Operating Instructions

LIFEPAK CR® PLUSLIFEPAK EXPRESS®

Defibrillatorswith ADAPTIV™ Biphasic Technology

DEFIBRILLATOR

LIFEPAK CR® PLUSLIFEPAK EXPRESS®

Defibrillators

with ADAPTIV™ Biphasic Technology

OPERATING INSTRUCTIONS

IMPORTANT

Rx only.

Device Tracking

The U.S. Food and Drug Administration requires defibrillator manufacturers and distributors to track the location of their defibrillators. If you have a defibrillator that is located somewhere other than the shipping address or the device has been sold, donated, lost, stolen, exported, or destroyed, or if the device was not obtained directly from Medtronic, please either call our product registration line at 888.351.LIFE (5433) or use the postage-paid address change card located in the back of this manual.

Responsibility for InformationIt is the responsibility of our customers to ensure that the appropriate person(s) who may use this defibrillator have access to the information in this manual, including general safety information provided in Section 1.

Revision HistoryThese operating instructions describe the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators with software Version 3.0 or later.

!USA

!USA

Medtronic Emergency Response Systems11811 Willows Road Northeast Redmond, WA 98052-2003 USATelephone: 425.867.4000Toll Free (USA only): 888.351.LIFE (5433)Fax: 425.867.4121Internet: www.medtronic-ers.com

www.medtronic.com

Medtronic Europe S.A.Medtronic Emergency Response SystemsRte. du Molliau 31Case postale 841131 TolochenazSwitzerlandTelephone: 41.21.802.7000Fax: 41.21.802.7900

LIFEPAK, LIFEPAK CR, and LIFEPAK EXPRESS are registered trademarks of Medtronic Emergency Response Systems, Inc. ADAPTIV, CODE-STAT, CHARGE-PAK, QUIK-PAK, QUIK-COMBO, and Shock Advisory System are trademarks of Medtronic Emergency Response Systems, Inc. Medtronic is a registered trademark of Medtronic, Inc. IrDA is a registered trademark of Infrared Data Association. Specifications are subject to change without notice. © 2006 Medtronic Emergency Response Systems, Inc. All rights reserved.

Publication Date: 08/2006 MIN 3201686-010 / CAT 26500-001361

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions iii© 2006 Medtronic Emergency Response Systems, Inc.

TABLE OF CONTENTS 1

1 IntroductionAbout Automatic External Defibrillators ............................................................................................... 1-2

Indications for Use........................................................................................................................ 1-2Contraindications ......................................................................................................................... 1-2Why the Need for Defibrillators .................................................................................................... 1-2Terminology.................................................................................................................................. 1-3Text Conventions.......................................................................................................................... 1-4

Safety Information ................................................................................................................................ 1-4Safety Terms ................................................................................................................................ 1-4General Warnings and Cautions .................................................................................................. 1-4

Symbols ............................................................................................................................................... 1-6About the LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillators .................................................. 1-8

Capabilities and Features............................................................................................................. 1-9

2 Getting StartedUnpacking and Inspecting Your LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator ..................... 2-2Where to Locate Your LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator ..................................... 2-3Controls, Indicators, and Labels .......................................................................................................... 2-4

Outside Controls, Indicators, and Labels ..................................................................................... 2-4Inside Features............................................................................................................................. 2-5

3 Using the DefibrillatorWarnings and Cautions ........................................................................................................................ 3-2Responding to a Sudden Cardiac Arrest emergency .......................................................................... 3-2

Basic Steps for Using the LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator....................... 3-3What to Do After Emergency Medical Personnel Arrive............................................................... 3-5What to Do After Using Your Defibrillator ..................................................................................... 3-5

Voice Instructions and Tones ............................................................................................................... 3-5Troubleshooting .................................................................................................................................... 3-6

iv LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions

4 Data StorageOverview of Data Storage .................................................................................................................... 4-2

Data Stored by Your Defibrillator .................................................................................................. 4-2Test and Service Data .................................................................................................................. 4-2Event and Test Log....................................................................................................................... 4-3

5 Caring for Your DefibrillatorMaintaining a State of Readiness ........................................................................................................ 5-2Cleaning Your Defibrillator ................................................................................................................... 5-2Replacing the CHARGE-PAK Battery Charger and the QUIK-PAK Electrode Packet ......................... 5-3

Replacing the CHARGE-PAK Battery Charger ............................................................................ 5-4Replacing the QUIK-PAK Electrode Packet.................................................................................. 5-6

Obtaining Authorized Service .............................................................................................................. 5-7Recycling Information .......................................................................................................................... 5-7

Recycling Assistance ................................................................................................................... 5-7Preparation................................................................................................................................... 5-7Recycling of Disposable Electrodes............................................................................................. 5-7Packaging..................................................................................................................................... 5-7

Supplies, Accessories, and Training Tools ........................................................................................... 5-7Warranty Information ........................................................................................................................... 5-7

6 Defibrillator Operating SettingsOperating Settings and Setup Configuration ....................................................................................... 6-2

A Specifications

B Shock Advisory System

C User’s Checklist

D Declaration of Conformity/Electromagnetic Compatibility Guidance

Index

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions v© 2006 Medtronic Emergency Response Systems, Inc.

LIST OF FIGURES

Figure 2-1 Outside Controls, Indicators, and Labels................................................................................2-4Figure 2-2 Inside Features.......................................................................................................................2-5Figure 2-3 Inside Features After Releasing the QUIK-PAK Electrode Packet..........................................2-6

Figure A-1 Biphasic Waveform.................................................................................................................A-1Figure A-2 Defibrillation-protected, Type BF Victim Connection ..............................................................A-2

LIST OF TABLES

Table 2-1 Outside Controls, Indicators, and Labels................................................................................2-4Table 2-2 Inside Features.......................................................................................................................2-6Table 2-3 Inside Features After Releasing the QUIK-PAK Electrode Packet..........................................2-7

Table 3-1 Troubleshooting During Victim Use ........................................................................................3-6

Table 4-1 Patient Reports.......................................................................................................................4-2Table 4-2 Defibrillator Patient Records...................................................................................................4-2Table 4-3 Event and Test Log Reports ...................................................................................................4-3

Table 5-1 Cleaning Methods ..................................................................................................................5-2

Table 6-1 Operating Settings..................................................................................................................6-2

Table B-1 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Adult ECGs........................................................................................................................B-1

Table B-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance with Active Pacemakers .................................................................................................................B-2

Table B-3 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Pediatric ECGs.......................................................................................................................B-2

Table D-1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ............................. D-3Table D-2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............................... D-4Table D-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ............................... D-5Table D-4 Recommended Separation Distances between Portable and Mobile RF Communications

Equipment and the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators...................... D-6

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions 1-1© 2006 Medtronic Emergency Response Systems, Inc.

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INTRODUCTION 1

This section provides background information about defibrillation and includes an overview of LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillator features.

About Automatic External Defibrillators page 1-2

Safety Information 1-4

Symbols 1-6

About the LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillators

1-8

1-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions

Introduction

ABOUT AUTOMATIC EXTERNAL DEFIBRILLATORS

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are automated external defibrillators (AEDs). For many years, defibrillators have been used only by medical professionals to treat victims in sudden cardiac arrest (SCA). Today, the ability of defibrillators to save lives is so widely recognized that people once trained to do only cardiopulmonary resuscitation (CPR) can now use defibrillators.

After electrode pads are applied to the victim’s chest, the defibrillator analyzes the victim’s heart rhythm. If a shockable rhythm is detected, the defibrillator will either deliver an intense pulse of electricity (shock) to the heart muscle (fully automatic model) or direct the responder to deliver the shock (semiautomatic model). The defibrillator delivers shocks through the electrode pads on the victim’s chest.

When this pulse of electricity is delivered, it is called defibrillation. Defibrillation is recognized for treating life-threatening heart beat irregularities, such as ventricular fibrillation, that cause SCA.

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.

Indications for UseThe LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are indicated for use on patients in cardiac arrest. The patient must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators may be used on children who are up to 8 years old or who weigh up to 25 kg (55 lb).

ContraindicationsNone known.

Why the Need for DefibrillatorsThe American Heart Association estimates that, in the USA alone, at least 250,000 people die each year of cardiac arrest. Of these, about 10,000 people might have been saved had they received immediate treatment from a defibrillator.

Sudden cardiac arrest is usually caused by a malfunction in the heart’s electrical system. Called ventricular fibrillation, this critical condition prevents the heart from pumping blood throughout the body. Ventricular fibrillation can cause death within seconds.

Defibrillation is a relatively simple procedure that involves placing electrode pads on a victim’s exposed chest and delivering an electrical shock to the heart. The externally-delivered shock often restores the heart’s electrical system to normal rhythm. Combined with CPR, defibrillation provides the most effective care for victims in cardiac arrest.


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TerminologyThe following terms appear in this manual.

AED Automated External Defibrillator. A device that evaluates the victim’s heart rhythm and delivers an electrical shock to the heart if a shockable rhythm is detected.

Cardiac arrest The termination of the heart’s pumping action resulting in the lack of a heartbeat or pulse and breathing.

CPR Cardiopulmonary resuscitation. This involves delivering rescue breathing and chest compressions to a victim in cardiac arrest.

Defibrillation Delivery of an electrical shock to the heart for the purpose of reversing ventricular fibrillation.

ECG Electrocardiogram. A composite picture of what is occurring electrically in the heart.

Fibrillation Chaotic activity of the heart’s electrical system. This condition can occur in the atria or the ventricles. When it occurs in the ventricles, they quiver in a rapid, chaotic manner, preventing them from pumping blood to the body.

Heart attack A nonspecific term referring to the death of heart muscle resulting from interruption of blood supply, often confused with cardiac arrest.

Impedance Resistance to the flow of electrical current through the body.

Joule The basic unit of energy delivered by a defibrillator.

LED Light emitting diodes.

Myocardial infarction The specific term for what is usually meant by heart attack; death of heart muscle resulting from an interruption of the blood supply to that area of myocardium.

Nonshockable rhythm A heart rhythm that is detected by the defibrillator that does not need a shock, but may need CPR.

Victim In this manual, the person suffering from cardiac arrest.

Responder In this manual, the person giving aid to a victim in cardiac arrest. Used interchangeably with user.

SAS Medtronic patented Shock Advisory System™.

Shockable rhythm A heart rhythm that is detected by the defibrillator as requiring a shock, for example, ventricular fibrillation.

User In this manual, the person giving aid to a victim in cardiac arrest. Used interchangeably with responder.

Ventricular fibrillation A life-threatening chaotic heart rhythm.

Ventricular tachycardia Rapid heart rhythm originating in the ventricle.


Introduction

Text ConventionsThroughout this manual, special text characters are used to indicate labels and voice instructions:

Operating control labels: CAPITAL LETTERS such as ON/OFF and SHOCK.

Voice instructions: ITALICIZED CAPITAL LETTERS such as STAND CLEAR.

SAFETY INFORMATION

This section provides important information to help you safely operate your defibrillator. Familiarize yourself with all of the terms, warnings, and symbols presented in this section.

Safety TermsYou may encounter the following terms in this manual and while using your defibrillator:

General Warnings and Cautions

Danger Immediate hazards that will result in serious personal injury or death to the user and/or the victim.

Warning Hazards or unsafe practices that could result in serious personal injury or death to the user and/or the victim.

Caution Hazards or unsafe practices that could result in minor personal injury to the user and/or the victim, product damage, or property damage.

WARNINGS!

Shock hazard.

The defibrillator delivers up to 360 joules of electrical energy. Unless properly used as described in this manual, this electrical energy may cause serious injury or death. Do not attempt to operate this defibrillator unless thoroughly familiar with this manual and the function of all controls, indicators, connectors, and accessories.

Do not insert a finger or any object other than the CHARGE-PAK™ into the well of the defibrillator.

Shock or fire hazard.

Do not immerse any portion of this defibrillator in water or other fluids. Avoid spilling any fluids on the defibrillator or its accessories. Do not clean with ketones or other flammable agents. Do not autoclave or sterilize this defibrillator or the accessories unless otherwise specified.

Possible fire or explosion.

Do not use this defibrillator in the presence of flammable gases or anesthetics. Use care when operating this defibrillator close to oxygen sources (such as bag-valve-mask device or ventilator tubing). Turn off gas source or move source away from patient during defibrillation.

Possible device shutdown.

When the attention symbol first appears on the readiness display, only a small number of shocks and monitoring time are available. Always keep a CHARGE-PAK™ in the defibrillator. Routinely check that the defibrillator is ready for use. Replace the CHARGE-PAK battery charger after each use of the defibrillator.


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Possible electrical interference with device performance.

Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference (RFI) which could affect the performance of this device. RFI may result in improper device operation, distorted ECG, failure to detect a shockable rhythm, or cessation of pacing. Avoid operating the device near cauterizers, diathermy equipment, cellular phones, or other portable and mobile RF communications equipment. Maintain equipment separation of at least 1.2 m (4 ft) and do not rapidly key EMS radios on and off. Contact a technical support representative if assistance is required.

Possible electrical interference.

Using cables, electrodes, or accessories not specified for use with this device may result in increased emissions or decreased resistance to electromagnetic interference which could affect the performance of this defibrillator or of equipment in close proximity. Use only parts and accessories specified in this manual.

Possible electrical interference.

This device may cause electromagnetic interference (EMI) especially during charge and energy transfers. EMI may affect the performance of equipment operating in close proximity. If possible, verify the effects of defibrillator discharge on other equipment prior to using the defibrillator in an emergency situation.

Possible improper device performance.

Using other manufacturers’ cables or electrodes may cause the defibrillator to perform improperly and invalidates the safety agency certification. Use only the parts and accessories specified in this manual.

Using damaged or expired equipment or accessories may cause the defibrillator to perform improperly and may injure the victim or the user.

Safety risk and possible equipment damage.

Monitors, defibrillators, and their accessories (including electrodes and cables) contain ferromagnetic materials. As with all ferromagnetic equipment, these products must not be used in the presence of the high magnetic field created by a Magnetic Resonance Imaging (MRI) device. The high magnetic field created by an MRI device will attract the equipment with a force sufficient to cause death or serious personal injury to persons between the equipment and the MRI device. This magnetic attraction may also damage the equipment. Skin burns will also occur due to heating of electrically conductive materials, such as patient leads and pulse oximeter sensors. Consult the MRI manufacturer for more information.

Possible equipment damage.

This defibrillator may be damaged by mechanical or physical abuse, such as immersion in water or dropping the defibrillator. If the defibrillator has been abused, remove it from use and contact a qualified service technician.

Using damaged or expired equipment or accessories may cause your defibrillator to perform improperly and may injure the victim or the user.

WARNINGS!


Introduction

SYMBOLS

The following symbols may appear in this manual and on the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. For more information about the readiness display symbols, refer to Section 2, Getting Started.

Symbol Explanation

OK Indicator. The defibrillator is ready for use.

Attention. On the readiness display—the internal battery is low. Refer to page 2-4 for more information about the readiness display.

Attention. On the CHARGE-PAK battery charger—consult the operating instructions. Refer to page 5-4 for more information about the CHARGE-PAK battery charger.

Attention. On the safety warning—consult the operating instructions. Refer to page 1-4 for more information about the warnings and cautions.

Attention. On the electrode pads—consult the operating instructions. Refer to page 2-6 for more information about electrode pads.

Warning, high voltage.

CHARGE-PAK battery charger indicator. Battery charger needs to be replaced.

Wrench indicator. There is a condition that prevents or could prevent normal defibrillator operation. Refer to page 5-7 for more information.

This end up.

Fragile/breakable. Handle with care.

Protect from water.

Power On/Off button.

Type BF patient connection.

OK


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Introduction

Not intended for use on children who are less than eight years of age or who weigh less than 25 kg (55 pounds).

Infant Child Reduced Energy Electrodes are not compatible with QUIK-COMBO defibrillation and therapy cables. To use Infant/Child Electrodes, connect Infant/Child Electrodes directly to the AED.

Not intended for use on adults.

Medtronic Emergency Response systems electrodes are latex-free.

Arrow indicates ON/OFF button location.

Symbol denoting a defibrillator and identifies the shock button.

Lot code.

Do not reuse—single use only.

Use By date shown: yyyy-mm-dd.

Refer to instructions for recycling procedure, page 5-7.

Refer to instructions for disposal procedure, page 5-3.

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on the proper disposal of this product.

Mark of conformity according to the European Medical Device Directive 93/42/EEC.

Canadian Standards Association certification for Canada and the United States.

Symbol Explanation

LOT YYWW

0123


Introduction

ABOUT THE LIFEPAK CR PLUS AND LIFEPAK EXPRESS DEFIBRILLATORS

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are designed for indoor and outdoor use. Each has two models available—fully automatic and semiautomatic. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The semiautomatic model evaluates the heart rhythm but requires the responder to press the shock button if a shockable rhythm is detected. Both models have voice instructions that guide the responder through the defibrillation process.

For USA audiences only.

Atmospheric pressure limitation.

Relative humidity range 5% to 95%.

Store in a cool, dry location (0° to 50°C or 32° to 122°F).

Recommended storage temperature: 15° to 35°C (59° to 95°F). Storage at extreme temperatures of -40° or 70°C (-40° or 158°F) is limited to seven days. If storage at these temperatures exceeds one week, the electrode shelf-life will be reduced.

Date of manufacture.

Do not place near an open flame.

Do not crush, puncture, or disassemble battery.

Rx Only Federal (U.S.) law restricts this device to sale by, or on the order of, a physician.

MIN Manufacturer’s Item Number.

CAT Catalog number used for placing orders.

Reorder number.

Symbol Explanation

!USA

35°C

15°C

95°F

59°F

50°C

0°C

122°F

32°F

YYYY

REF


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Introduction

Capabilities and FeaturesThe following paragraphs introduce specific features found in the defibrillators.

Accessories

The defibrillator arrives with an installed CHARGE-PAK battery charger, one preconnected QUIK-PAK™ electrode packet, and the operating instructions. Refer to Section 5 for other accessories.

Automated Operation

Voice instructions guide the responder through the defibrillation process.

The fully automatic defibrillator requires no operator interaction beyond placing the electrode pads on the victim. If the defibrillator detects a shockable rhythm, it warns the responder prior to delivering any shock, and then delivers a shock without operator interaction.

The semiautomatic defibrillator has a highly visible shock button that the responder must press when the defibrillator issues a shock voice instruction.

Automatic Self-Test

The defibrillator tests itself each week and every time you turn it on. In addition, every month, the defibrillator performs a more extensive self-test. This self-test checks the defibrillator’s circuitry to verify that it is ready for use.

Customized Setup

The defibrillator is shipped ready to use with the preprogrammed ADAPTIV biphasic escalating energy protocol. The defibrillator also has several operating settings that can be customized. These include the defibrillator ID, voice prompt volume, energy sequence, and protocol.

Data Management

The defibrillator digitally stores data when it is turned on and the electrode pads are successfully applied to the victim. The stored data includes date and time, ECG data, and the number of shocks. The defibrillator also stores the results of the automatic self-tests.

Stored data can be transferred to a PC by means of a serial infrared link, the IrDA® port. A data transfer and management program running on the PC transfers event and test data from the defibrillator.

Defibrillation Electrodes (Pads)

When applied to the victim, Medtronic QUIK-PAK™ defibrillation electrodes (pads) work with the defibrillator to monitor the heart rhythm and identify when a shock should be delivered. If victim care is transferred to emergency medical personnel, these electrode pads can be disconnected from the defibrillator and reconnected to other AEDs or defibrillators that are compatible with QUIK-COMBO™ electrodes. For infants or children who are less than eight years of age or weigh less than 25 kg (55 lbs), use Infant/Child Reduced Energy Defibrillation Electrodes. These electrodes reduce the energy delivered by the AED to the victim by one fourth. Keep all electrode pads with the AED.

Defibrillation Waveform

The defibrillation shock, using ADAPTIV Biphasic technology, is delivered in the form of a biphasic truncated exponential (BTE) defibrillation waveform.

Heart Rhythm Analysis

The Medtronic patented Shock Advisory System™ evaluates the victim’s heart rhythm. Refer to Appendix B for further information.


Introduction

Motion Detection

This patented motion system detects victim or operator motion that could affect the heart rhythm evaluation. Heart rhythm evaluation is interrupted if the defibrillator detects motion.

Power System

Power is provided by a rechargeable internal lithium battery. The internal battery supplies power to operate the defibrillator. A replaceable CHARGE-PAK battery charger provides a trickle charge for the internal battery. It is important to keep a fresh CHARGE-PAK battery charger in the defibrillator, even when the defibrillator is stored.

Readiness Display

This easy-to-read visual display indicates if the defibrillator is ready for use or if it needs attention.


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GETTING STARTED 2

This section provides an orientation to the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators and describes how to prepare the defibrillator for use.

Unpacking and Inspecting Your LIFEPAK CR Plus or LIFEPAK EXPRESS Defibrillator

page 2-2

Where to Locate Your LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator

2-3

Controls, Indicators, and Labels 2-4


Getting Started

UNPACKING AND INSPECTING YOUR LIFEPAK CR PLUS OR LIFEPAK EXPRESS DEFIBRILLATOR

To help ensure the integrity of your defibrillator and to verify that it is complete, perform the initial inspection as follows:

1 Remove your defibrillator and examine its outside for signs of damage that may have occurred during shipping.

2 Check the remaining contents in the box against the sales order.

3 View the OK symbol in the readiness display. This indicates your defibrillator is ready for use. If the OK symbol is not visible, contact your local Medtronic representative.

4 Notice the Use By date.The Use By date is located below the readiness display. This date tells you when the electrode packet and battery charger must be replaced.

5 Check the defibrillator speaker by performing the following:

Note: This is only a speaker check. Do not respond to the voice instructions.

• Press the ON-OFF button to open and turn on your defibrillator.Confirm that the voice instructions sound.

• Press and hold the ON-OFF button for approximately 2 seconds to turn off your defibrillator.Three tones will sound.

6 Close and latch the lid. Do not reopen the lid unless necessary.Doing so will reduce battery power.

If you have any questions about your defibrillator, please call your local Medtronic representative.

Save the shipping container and inserts in case you need to reship the defibrillator in the future.

CAUTION!

After completing an initial inspection, do not open the lid unnecessarily. Each time you open the lid, the defibrillator turns on and internal battery power is reduced. After 30 minutes of cumulative on time, the CHARGE-PAK indicator appears on the readiness display indicating the CHARGE-PAK battery charger and the QUIK-PAK electrode packet should be replaced.


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Getting Started

WHERE TO LOCATE YOUR LIFEPAK CR PLUS OR LIFEPAK EXPRESS DEFIBRILLATOR

The defibrillator should be easy to reach in a location free of obstacles. This could include a location near existing emergency equipment, such as fire extinguishers and first-aid kits. When considering location, avoid areas that expose the defibrillator to moisture, dust, or extreme temperatures. Recommended storage temperature is 15° to 35° C (59° to 95° F). Storage at higher temperatures will shorten the life of the battery and electrodes.

Although the defibrillator and electrodes are designed to withstand environmental temperature fluctuations between -40° C to 70° C (-40° F to 158° F), storage at extreme temperatures of -40° C or 70° C (-40° F or 158° F) is limited to one week. If storage at these temperatures exceeds one week, the electrode shelf-life will be reduced. Refer to Appendix A, page A-3 environmental specifications information. You can place your defibrillator on a stable surface, or you can mount it using the wall mount bracket accessory. Contact your local Medtronic representative.


Getting Started

CONTROLS, INDICATORS, AND LABELS

This section introduces you to the controls, indicators, and labels on the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators.

Outside Controls, Indicators, and LabelsControls, indicators, and labels on the outside of the defibrillator are identified in Figure 2-1 and described in Table 2-1.

Figure 2-1 Outside Controls, Indicators, and Labels

Table 2-1 Outside Controls, Indicators, and Labels

Feature Description

Readiness Display There are four indicators that can appear when your defibrillator is turned off. These indicators allow you to determine, just by looking at the defibrillator, whether it’s ready for use or needs attention. They include the following:

The OK indicator appears when the defibrillator is turned off and ready for use.

The CHARGE-PAK indicator appears when the CHARGE-PAK battery charger needs to be replaced or is not installed in the defibrillator. If needed, the defibrillator can be used in an emergency.

The attention indicator appears when the internal battery is not fully charged. When this indicator first appears, the internal battery can power the defibrillator for a minimum of 6 shocks or 42 minutes.

The wrench indicator appears when a condition prevents or could prevent the defibrillator from operating normally.

Lid The top of the defibrillator.

ON-OFF button The ON-OFF button opens the defibrillator lid and turns the defibrillator on. Pressing and holding the button for approximately 2 seconds after the lid is open turns off the defibrillator.

Carrying handle

Safety warnings

Serial number label

Lid

CHARGE-PAK battery charger

Readiness

On-Off button

IrDA port

Use Bydate display

OK


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Getting Started

Inside FeaturesThe inside features of the defibrillator are designed to make it easy to use during a cardiac arrest event. When you press the ON-OFF button, the lid opens, the defibrillator turns on, and you see the electrode packet and its release handle as shown in Figure 2-2. Table 2-2 describes the inside features.

Figure 2-2 Inside Features


The CHARGE-PAK battery charger delivers a trickle charge to the internal battery. The battery charger can provide a charge for approximately two years, as long as the defibrillator is not used.

IrDA port The Infrared Data Association defines specifications for infrared wireless communications. The IrDA port provides wireless communications for transferring data from your defibrillator to a PC.

Carrying Handle The carrying handle is used to transport the defibrillator.

Safety Warnings Safety warnings provide important information concerning the defibrillator’s use and service.

Serial Number Label The serial number label includes the defibrillator identification number.

Table 2-1 Outside Controls, Indicators, and Labels (Continued)

Feature Description

Quick reference card

Use By date

Electrode packet

Electrode packet release handle

Electrode packetanchor pin


Getting Started

After you pull the electrode packet release handle and tear open the electrode packet, you will see the features shown in Figure 2-3

Figure 2-3 Inside Features After Releasing the QUIK-PAK Electrode Packet

Table 2-2 Inside Features

Feature Description

Quick reference card This card provides abbreviated graphic directions for using your defibrillator to treat a victim in cardiac arrest.

Use By date Use By date shown (yyyy-mm-dd) can be viewed through the defibrillator lid when it is closed.

Electrode packet The QUIK-PAK electrode packet is preconnected to the defibrillator. This packet contains a set of electrode pads.

Electrode packet release handle When you pull this handle, the electrode packet tears open.

Electrode packet anchor pin This pin securely positions the electrode packet to the defibrillator.

Speaker

Electrode indicators

Blue plastic

Shock button

Electrode connector

Electrode pads


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Getting Started

Table 2-3 Inside Features After Releasing the QUIK-PAK Electrode Packet

Feature Description

Speaker This projects the voice instructions that lead you through the defibrillation process.

Electrode indicators The electrode indicators flash red until the pads are applied to the victim’s exposed chest. When the pads are successfully applied, the indicators turn solid green and the defibrillator can perform an analysis.

In addition, electrode indicators briefly flash when the defibrillator performs an automatic self-test.

Blue plastic The plastic liner protects the conductive adhesive gel until the electrode pads are used.

Electrode pads The electrode pads are applied to the victim’s exposed chest; they transfer the defibrillation energy (shock) to the victim. The electrode pads must be removed from the blue plastic before applying them to the victim.

SHOCK button The SHOCK button is only provided on the semiautomatic model. When pressed, this button delivers a shock to the victim. You cannot deliver a shock to a victim unless the defibrillator instructs you to do so.

Electrode connector The electrode connector is used to connect the electrode pads to the defibrillator. To aid in victim transport, the connector can be unplugged from the defibrillator and plugged into another AED or defibrillator equipped for QUIK-COMBO electrodes.


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USING THE DEFIBRILLATOR 3

This section provides information and instructions for using the LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator on a victim in cardiac arrest.

Warnings and Cautions page 3-2

Responding to a Sudden Cardiac Arrest emergency

3-2

Voice Instructions and Tones 3-5

Troubleshooting 3-6


Using the Defibrillator

WARNINGS AND CAUTIONS

To help ensure safe use of the defibrillator, completely familiarize yourself with the following warnings and cautions.

RESPONDING TO A SUDDEN CARDIAC ARREST EMERGENCY

If not treated, sudden cardiac arrest (SCA) will cause death. In an SCA situation, it is important to remember to immediately call for help and activate your emergency response system.

WARNINGS!

Incorrect rhythm interpretation.

Performing CPR or otherwise handling or transporting the victim while the defibrillator is evaluating the heart rhythm can cause an incorrect or delayed diagnosis. Keep the victim as still as possible while the defibrillator is attached and do not transport the victim.

Shock hazard.

When instructed “Do not touch patient,” “Stand by,” or “Everyone clear,” remain still, do not touch the defibrillator, patient, electrode pads or any material in contact with the patient. Make sure no one is touching the patient when the defibrillator shocks the patient.

Shock hazard.

To remove an unwanted charge, disconnect the electrode cable from the defibrillator, wait for the defibrillator to automatically remove the charge, or turn off the defibrillator.

Possible fire, burns, and ineffective energy delivery.

During defibrillation, material in contact with the electrode pads can cause electrical sparks, skin burns, and divert important defibrillating energy away from the heart. Place electrode pads so that they adhere to the skin completely. Do not allow the electrode pads to touch each other, medication patches, dressings or any other material on the patient’s chest.

During defibrillation, air pockets between the skin and electrode pads can cause skin burns. To help prevent air pockets, make sure electrode pads completely adhere to the skin. Do not use damaged, expired, or dried-out electrode pads.

CAUTION!


Before using the defibrillator, disconnect all equipment from the patient that is not defibrillator-protected.


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Basic Steps for Using the LIFEPAK CR Plus or LIFEPAK EXPRESS DefibrillatorResponding to an SCA emergency using the defibrillator involves these basic steps:

Determine if the victim is in SCA. A person in SCA will not respond when you try to shake him or her.

Check for breathing by listening next to the victim’s mouth and looking for chest movement.

Use your defibrillator only if the victim is not responding, not moving, and not breathing normally or not breathing at all. If in doubt, use your defibrillator.

Place your defibrillator near the victim and on the side next to you. Press the ON/OFF button to open the lid and turn on your defibrillator. Remain calm. Your defibrillator will guide you through the defibrillation process.

Expose the victim’s chest. If the chest is excessively hairy, quickly shave the hair in the area where you will place the pads. If the chest is dirty or wet, wipe the chest clean and dry. If there are medicine patches on the victim’s chest, remove them.

Hold down the left side of the electrode packet with one hand and pull the red packet handle down with the other. The electrode packet tears open.

Tear open the packet completely to remove the pads. A small piece of the packet will remain attached to your defibrillator.



Separate the electrode pads, one at a time, from the blue plastic. Use these pads on adults or children 8 years of age or more, who weigh 25 kg (55 pounds) or more. For infants or children who are less than 8 years of age or who weigh less than 25 kg (55 pounds), special electrodes are needed. Refer to page 5-7 for more information.

WARNING!If you cannot determine a child’s age or weight, or if special infant/child electrodes are not available, proceed with the existing electrode pads, and continue on to the next step.

Apply the electrode pads to the victim’s bare chest (exactly as shown in the picture on the pads). Be sure to press firmly so that the pads completely adhere to the victim’s chest.

Note: Be sure you do not place the electrode pads over an implanted device such as an implanted pacemaker or ICD. An indication of an implant is a protrusion in the chest skin and a scar. If you are in doubt, apply the pads as shown on the labels.

Listen to voice instructions and do not touch the victim unless instructed to do so.

If the defibrillator heart rhythm analysis determines that a shock is needed, the defibrillator will announce PREPARING TO SHOCK, and then instruct you to PRESS FLASHING BUTTON to administer a shock (semiautomatic model) or it will announce PREPARING TO SHOCK, and then automatically administer a shock without requiring further action (fully automatic model).

Do not touch the victim while a shock is delivered.

Regardless of which model you have, continue to follow the voice instructions.

Do not remove the pads or disconnect them from the defibrillator until emergency medical personnel arrive. If the victim starts moving, coughing, or breathing regularly, place the victim in the recovery position (as instructed in CPR training) and keep him or her as still as possible.


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What to Do After Emergency Medical Personnel ArriveWhen emergency medical personnel arrive, tell them what actions you have taken. Tell them how long the victim has been unconscious, if you delivered shocks, the number of shocks delivered, and if you performed CPR.

Do not worry if you cannot recall precisely what happened. Your defibrillator makes a digital recording of heart rhythms and shocks that can be transferred to a computer at a later time. Refer to Section 4 for information on transferring victim data.

Without removing the electrode pads from the victim, emergency medical personnel can disconnect the electrode pads from the defibrillator and reconnect them to another defibrillator or AED that has a compatible QUIK-COMBO cable.

To disconnect the electrode pads:

1 Pull the electrode cable straight out from the defibrillator.

2 Remove the electrode packet anchor pin from the slot in the defibrillator.

3 Press the ON-OFF button and close the lid to turn off the defibrillator.

What to Do After Using Your DefibrillatorAfter you use your defibrillator to respond to an SCA emergency, complete the following tasks:

1 If the defibrillator is turned on, press and hold the ON-OFF button for approximately 2 seconds to turn it off.

2 Clean the defibrillator and its accessories according to the instructions provided in Table 5-1, page 5-2. Use only the cleaning agents identified in Table 5-1.

3 Transfer data, if desired.

4 Replace the CHARGE-PAK battery charger. (Refer to page 5-4.)

5 Install a new QUIK-PAK electrode packet. (Refer to page 5-6.)

6 Close the lid and verify that the OK symbol appears in the readiness display, indicating that the defibrillator is ready for use. If the attention symbol appears after you replace the battery charger, the internal battery needs additional time to reach an adequate charge capacity.

7 Dispose of the used electrode pads, any unused spare electrode pads, and the battery charger. (Refer to Recycling Information, page 5-7.)

VOICE INSTRUCTIONS AND TONES

Defibrillator voice instructions provide clear, step-by-step instructions for responding to a victim in cardiac arrest. In addition, your defibrillator may emit sounds that alert you to the actions that the defibrillator is performing.

Note: A few seconds may pass between voice instructions and tones. Always wait for further instructions before taking action.

Note: Some voice instructions will repeat during the defibrillation process.



TROUBLESHOOTING

This section explains problems you may encounter while using the LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator. For information about keeping your defibrillator in a state of readiness, refer to Section 5.

Table 3-1 Troubleshooting During Victim Use

Problem Possible Cause What To Do

CHECK PADS FOR GOOD CONTACT or CHECK CONNECTOR voice instructions are heard

Inadequate connection to the defibrillator • Be sure that the connector is completely inserted.

Electrode pads are not properly adhered to the victim

• Firmly press the pads on the victim’s skin.

• Clean, shave, and dry the victim’s skin before placing pads on skin.

Electrode pads are dry, damaged, or have passed the expiration date

• Replace the pads.

Electrode pads are not removed from the blue plastic

• Remove the pads from the blue plastic and apply them to the victim’s chest.

Defibrillator cannot deliver the required shock

Defibrillator internal battery power is low • Administer CPR if the victim is not responding, not breathing normally, or not moving.

Voice instructions sound faint or distorted

Defibrillator internal battery power is low • Administer CPR if the victim is not responding, not breathing normally, or not moving.

MOTION DETECTED and STOP MOTION voice instructions are heard

Victim movement because of location • Move the victim to a stable location, if possible.

Victim movement because of breathing • Stop CPR during analysis.• Check victim for normal

breathing.

Vehicle motion • Stop vehicle during analysis, if possible.

Electrical/radio frequency interference • Move communication or other suspected devices away from the defibrillator when possible.


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Defibrillator does not deliver voice instructions or beeping tones after you open it (turn it on)

Depleted internal battery • Administer CPR if the victim is not responding, not breathing normally, or not moving.

• Replace the CHARGE-PAK battery charger as soon as possible. After the OK symbol appears on the readiness display, return the defibrillator to service.

• Contact authorized service personnel.

The readiness display is blank

The defibrillator has been turned on • Normal condition when the defibrillator is in use.

Operating temperature is too low or too high

• Operate the defibrillator within 0° to 50°C (32° to 122°F).

LCD not operating properly • Contact authorized service personnel.

Table 3-1 Troubleshooting During Victim Use (Continued)

Problem Possible Cause What To Do


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DATA STORAGE 4

This section describes the data that the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators store when used in an SCA event.

This manual does not provide instructions for how to hand off defibrillation data to the emergency medical system or hospital personnel. Because this process varies from area to area, check with the emergency medical system administration for information and directions.

Overview of Data Storage page 4-2


Data Storage

OVERVIEW OF DATA STORAGE

Each time you use the LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator, it digitally saves data about the victim that can be transferred to a PC. This data can be provided to emergency medical personnel or hospital personnel to aid in case review for quality control, training, and research purposes. We recommend that you become familiar with their local requirements for reporting a use of the defibrillator and for providing use data. For assistance in retrieving data from the defibrillator, contact your local Medtronic sales or service representative.

Data Stored by Your DefibrillatorWhenever you turn on your defibrillator and connect it to a victim, it automatically stores data about the victim. When this data is transferred to a data management system for review, three reports are available: an Event Log, Continuous ECG, and a Summary. Table 4-1 describes these reports.

Your defibrillator can store up to two records: one for the current victim and one for the previous victim. When you use your defibrillator, it is important that you transfer this data as soon as possible after use to free up storage.

The Complete Record for the current victim includes the Continuous ECG and Event Log. If you treat a second victim, the first victim’s Complete Record will be reformatted into a Summary report. If you treat a third victim, all of the first victim’s data will be deleted and the second victim’s Complete Record will be reformatted into a Summary Report. Refer to Table 4-2.

If you turn your defibrillator on and off without attaching electrode pads to a victim, the defibrillator will not create a new record and the records in the defibrillator will not be altered. The defibrillator deletes previous data only after it is connected to a new victim.

After you transfer data records to a PC, the defibrillator will disallow repeat transmissions. However, service personnel may access device records, if necessary.

Test and Service DataYour defibrillator stores a test log consisting of the most recent auto-tests, power cycles, and CHARGE-PAK battery charger replacements. The test log lists the test results and any errors detected. The test log data is available only to service personnel or to users through the data management system.

Table 4-1 Patient Reports

Report Type Description

Event Log A chronological log of all events. An event is a condition noted by the defibrillator. Events are listed on page 4-3.

Continuous ECG Twenty minutes of the victim’s ECG rhythm beginning when the victim is connected to the defibrillator and ending when the defibrillator is turned off.

Summary Combines the Event Log and a sampling of continuous ECG rhythms associated with certain events.

Table 4-2 Defibrillator Patient Records

Complete Record Summary

Current Victim

Previous Victim 0


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Data Storage

Event and Test LogTable 4-3 lists the types of events that may be annotated on event and test log reports.

Table 4-3 Event and Test Log Reports

Event Log Test Log

Power On Self-Test Power On

Connect Electrodes Self-Test Pass/Fail

Patient Connected User Power On

Initial Rhythm* CHARGE-PAK Changed

Analysis X* CHARGE-PAK

Shock Advised Fault Log

Charge Complete

SHOCK X-XXXJ*

Shock X Abnormal

No Shock Advised

CPR Prompt

Stop CPR Prompt

Check Patient*

Charge Removed

Low Battery

Motion

Analysis Stopped*

Out of Event Memory

Out of Waveform Memory

Power Off

*These events include ECG samples in the Summary Report.


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CARING FOR YOUR DEFIBRILLATOR 5

This section explains how to help keep your LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator in good working condition. Cared for properly, your defibrillator is built to give you many years of service.

Maintaining a State of Readiness page 5-2

Cleaning Your Defibrillator 5-2

Replacing the CHARGE-PAK Battery Charger and the QUIK-PAK Electrode Packet

5-3

Obtaining Authorized Service 5-7

Recycling Information 5-7

Supplies, Accessories, and Training Tools 5-7

Warranty Information 5-7


Caring for Your Defibrillator

MAINTAINING A STATE OF READINESS

Your LIFEPAK CR Plus or LIFEPAK EXPRESS defibrillator does not require routine maintenance. It performs an automatic self-test once a week and every time you turn it on. The electrode indicators briefly flash during the test. If the automatic self-test detects a condition that requires attention, the OK symbol in the readiness display will fade and either the CHARGE-PAK symbol, the ATTENTION symbol, or the WRENCH symbol will appear, depending on the type of condition detected.

On a regular basis, you should do the following:

• Check to make sure that the OK symbol is visible in the readiness display.

• Check the Use By date on the electrode packet (visible through the defibrillator lid in the upper right corner) and all other electrode packets. If the date has passed, replace the electrode packet and the battery charger.

• Check other emergency supplies that may be stored with your defibrillator.

When establishing your local inspection schedule, consider how often your defibrillator will be used and how familiar the operators are with using a defibrillator. For example, if the defibrillator is used only rarely, monthly inspections may be appropriate. An inspection checklist is provided in Appendix C.

CLEANING YOUR DEFIBRILLATOR

CAUTION!


Do not clean any part of the defibrillator or accessories with bleach, bleach dilution, or phenolic compounds. Do not use abrasive or flammable cleaning agents. Do not steam, autoclave, or gas-sterilize the defibrillator or its accessories.

Table 5-1 Cleaning Methods

Item Cleaning Method Cleaning Agent

Exterior case, readiness display, and crevices

Clean with damp sponge or cloth

Nonabrasive soap and water

Quaternary ammonium compounds

Rubbing (isopropyl) alcohol

Peroxide (peracetic acid) solutions


None None, dispose of/recycle after use

Electrode Pads None, do not remove electrode pads from the packet

None, dispose of/recycle after use

Carrying case Wipe with damp cloth or sponge Water

Quick Reference Card Wipe with damp cloth or sponge Water


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REPLACING THE CHARGE-PAK BATTERY CHARGER AND THE QUIK-PAK ELECTRODE PACKET

The CHARGE-PAK battery charger is a replaceable, nonrechargeable battery cell that charges your defibrillator’s internal battery. The internal battery provides the power for your defibrillator. To prevent damage to the internal battery, always keep the battery charger in place, including during storage or shipping.

The QUIK-PAK electrode packet contains the pads that transfer the defibrillation energy to the victim. The packet should remain connected to the defibrillator and unopened until required for an SCA emergency. QUIK-PAK electrode pads are not reusable.

When installed, these two accessories allow your defibrillator to stand by for use for approximately two years. The electrode packet Use By date is programmed into the battery charger. When the date is reached, the CHARGE-PAK symbol appears in the readiness display, indicating both the battery charger and electrode packet need to be replaced.

Use the Medtronic replacement kit to replace the CHARGE-PAK battery charger and the QUIK-PAK electrode packet as follows:

• After using the defibrillator

• If the CHARGE-PAK symbol appears in the readiness display

• When the Use By date is reached or passed

The replacement kit includes a CHARGE-PAK battery charger, one or two QUIK-PAK electrode packets, and a CHARGE-PAK battery discharger. The discharger depletes a used battery charger so that it is ready for recycling or disposal.

Follow instructions provided in the replacement kit for battery charger and electrode packet recycling/disposal. Contact your local Medtronic representative.

WARNING!

Possible explosion or fire.

The CHARGE-PAK battery charger is not rechargeable. Do not attempt to recharge, open, crush, or burn the battery, or it may explode or catch fire.



Replacing the CHARGE-PAK Battery Charger

To replace the CHARGE-PAK Battery Charger:

1 Press the release latch (in the direction of the arrow) to remove the used battery charger. The battery charger springs outward from the defibrillator.

2 Insert the new battery charger into your defibrillator and push until you hear it click into position.

3 Confirm that the symbol disappears and that the OK symbol appears in the readiness display.

Note: If the symbol appears after you replace the battery charger, the internal battery is very low and needs time to charge. It may take up to three days if you had the defibrillator on for a long time or if you delivered many shocks. The OK symbol appears when the internal battery is charged.

Remember: If the defibrillator is needed for an emergency,

attempt to use it even if the symbol is visible.

CAUTION!

Keep the defibrillator at temperatures between 0° – 50°C (32° – 122°F) while the new battery charger charges the internal battery. The internal battery may not charge effectively at lower temperatures. Temperatures exceeding 50° C (122°F) for longer than seven days can permanently damage the internal battery.


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To discharge and dispose of a used battery charger:

1 Insert the discharger into the used battery charger.

Note: Do not attempt to remove the discharger once it is in place.

2 Let the discharger fully deplete the battery charger. Wait at least 9 days.

3 Place the used battery charger in the trash or recycle it.



Replacing the QUIK-PAK Electrode Packet

To replace the QUIK-PAK Electrode Packet:

1 Press the ON/OFF button to open the defibrillator lid (voice instructions will sound).

2 Press and hold down the ON/OFF button for 3 seconds to turn off the defibrillator and save battery power.

3 Remove the outdated or used electrode packet:

a Unplug the electrode connector from the connector receptacle.

b Slide the anchor pin from the slot.

c Discard the outdated or used electrode packet according to local regulations.

4 Install the new electrode packet:

a Slide the anchor pin into the slot.

b Plug the electrode connector into the receptacle.

c Ensure that the new electrode packet is centered on the defibrillator and is tucked behind the lip before closing the lid.

d Close the lid. Confirm that the packet Use By date is visible through the upper right-hand corner of the lid.

b

c

a

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OBTAINING AUTHORIZED SERVICE

The WRENCH indicator appears on the readiness display if the defibrillator requires service. Contact authorized service personnel only. In the USA, contact Medtronic at 1.888.351.LIFE (5433). Outside the USA, contact your local Medtronic representative. Be prepared to provide the following information:

• Model number and MIN number (part number)

• Serial number

• Description of the problem based on your observations

RECYCLING INFORMATION

Recycle the defibrillator and its accessories at the end of their useful lives.

Recycling AssistanceItems should be recycled according to national and local regulations. Contact your local Medtronic representative for assistance.

PreparationItems should be clean and contaminant-free prior to being recycled.

Recycling of Disposable ElectrodesAfter using disposable electrodes, follow your local clinical procedures for recycling.

PackagingPackaging should be recycled according to national and local regulations.

SUPPLIES, ACCESSORIES, AND TRAINING TOOLS

If possible, we recommend that you have an extra QUIK-PAK Electrode Packet and CHARGE-PAK Battery Charger on hand. In addition, there are other useful accessories available. For example, you can buy Infant/Child Reduced Energy Defibrillation Electrodes for use with your defibrillator on children who are less than 8 years of age or weigh less than 25 kg (55 lb). Contact your local Medtronic representative.

WARRANTY INFORMATION

Refer to the warranty statement included in the accessory kit shipped with this product. For duplicate copies, contact your local Medtronic representative. In the USA, call 1.800.442.1142. Outside the USA, contact your local Medtronic representative.

WARNING!

Shock hazard.

Do not disassemble the defibrillator. It contains no operator-serviceable components and dangerous high voltages may be present. Contact authorized service personnel for repair.


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DEFIBRILLATOR OPERATING SETTINGS 6

This section introduces the operating settings that are adjustable on the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators.

Operating Settings and Setup Configuration page 6-2


Defibrillator Operating Settings

OPERATING SETTINGS AND SETUP CONFIGURATION

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators have 12 operating settings that affect how it functions. The settings range from defining the time and date used by the defibrillator, to the energy sequence and protocol of the shocks delivered. This group of operating settings are the defibrillator’s setup configuration.

Each operating setting is preset to a default value based on clinical guidelines and does not need to be changed unless your medical director desires performance characteristics that are different from the default setting.

Table 6-1 identifies operating settings in the setup configuration, describes each setting, including possible options, and identifies the preset defaults.

Table 6-1 Operating Settings

Operating Settings Description Default Setting

Device ID Device ID is a unique identifier (ID) assigned to each defibrillator used for tracking the location of defibrillators. If you have multiple defibrillators at your location, you should give each a unique name, such as Building 1, Building 2, and so on. When you transfer event data from the defibrillator to a PC, the defibrillator ID will be included in the transferred data.

Serial Number

Energy Sequence Energy sequence defines the energy levels used by the defibrillator.

The energy level choices are: 150, 175, 200, 225, 250, 275, 300, 325, 360.

Level 1 – 200 joules



Energy Protocol Energy protocol determines how the defibrillator delivers successive shocks. There are two options for this setting: flexible or fixed.

Flexible sequence means the energy delivered for a shock increases only if an analysis immediately following a shock results in another SHOCK ADVISED decision. For example, if the defibrillator energy sequence is set up as 200, 300, 360, flexible sequence means that the energy delivered for the first shock is 200 joules. If the arrhythmia is terminated by shock 1 and the next analysis results in a SHOCK ADVISED decision, the energy will not increase for the next shock. However, if the arrhythmia is not terminated by shock 1 and the next analysis results in a shock advised decision, the energy will increase to 300 joules, and so on.

Fixed sequence means that the energy delivered after the first shock of 200 joules increases from 200 to 300, and then to 360 joules, regardless of the post-shock ECG rhythm and subsequent analysis.

Flexible


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CPR Time 1

CPR Time 2

The CPR Time 1 and CPR Time 2 settings define the time interval for performing CPR after a shock or after a no shock advised decision.

The choices for CPR Time 1 and CPR Time 2 are 15, 30, 45, 60, 90, 120, and 180 seconds.

CPR Time 1 – 60 sec

CPR Time 2 – 60 sec

Device Date

Device Time

Device date and device time sets the current date and time.

Pacific Standard Time and Date

Turn-On Prompt This setting determines whether you hear only tones, or tones and the voice prompt, CALL FOR HELP NOW, when you open the lid and the defibrillator turns on. Choices are Voice and Tones.

Voice

Voice Prompt Volume This setting sets the voice prompt volume to MEDIUM or HIGH.

High

Pulse Prompt The pulse prompt setting determines whether the defibrillator prompts you to check the victim’s pulse (appropriate for medically trained users) or to check the victim for signs of circulation such as breathing and movement (appropriate for lay users). Choices are Check Pulse, Check Breathing, or Check Circulation.

Per customer order

Stack Shocks When set to OFF, the Stack Shocks option eliminates the analysis after each shock and inserts prompting for CPR after each (a single) shock. This eliminates the three-shock stack. CPR is prompted regardless of the ECG rhythm after the shock. The CPR time following the shock is determined by the CPR Time 1 setting selected. Choices for Stack Shocks option are ON or OFF.

When set to ON, an analysis will occur after shocks, and up to three shocks in a row may be delivered (three-shock stack).

On

Pulse Check When set to Never, the Pulse Check option removes all prompting for pulse checks. The other Pulse Check settings available allow pulse checks only after every No Shock Advised (NSA) decision, after the second NSA decision and thereafter, or Always (after shocks, NSA and CPR).

Always

Table 6-1 Operating Settings (Continued)




Motion Detection The motion detection setting is used to determine if motion detection is active or not active during analysis.

When motion detection is On, the defibrillator stops analysis for up to 10 seconds if it detects any victim motion. The defibrillator notifies the responder of the problem. The defibrillator will resume analysis after 10 seconds, even if motion is still present. When motion detection is Off, analysis is not inhibited, regardless of any victim motion.

On

Time Zone This setting sets the time zone for the location of the defibrillator. Choices are 74 time zones with universal time code (UTC).

None

Table 6-1 Operating Settings (Continued)


LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions© 2006 Medtronic Emergency Response Systems, Inc.

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APPENDIX A

SPECIFICATIONS A

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions A-1© 2006 Medtronic Emergency Response Systems, Inc.

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Specifications

SPECIFICATIONS

All specifications are at 20°C (68°F) unless otherwise stated.

Defibrillator

Figure A-1 Biphasic Waveform

Waveform: Biphasic Truncated Exponential, with voltage and duration compensation for victim impedance. See Figure A-1.

Output Energy Sequence:

Multiple levels, configurable from 150 joules to 360 joules.

The following specifications apply from 25 to 200 ohms. Voltage compensation is limited to the voltage that would result in delivery of 360 joules into 50 ohms.

Output Energy Accuracy:

±10% into 50 ohms±15% into 25 to 100 ohms

Waveform Parameters:

Impedance (Ω) Phase 1 Duration (ms) Phase 2 Duration (ms) Tilt (%)

Min Max Min Max Nominal

25 5.1 6.0 3.4 4.0 77.5

50 6.8 7.9 4.5 5.3 65.8

100 8.7 10.6 5.8 7.1 52.6

125 9.5 11.2 6.3 7.4 47.8

Shock Advisory System: An ECG analysis system that advises whether a shock is appropriate, meets rhythm recognition criteria specified in the American Association of Medical Instrumentation standard DF39.

The device allows a defibrillation shock only if the Shock Advisory System advises defibrillation.

Device Capacity: LIFEPAK CR Plus defibrillator — Thirty (30) full discharges or 210 minutes of “ON time” with a fully charged device.

LIFEPAK EXPRESS defibrillator — Twenty (20) full discharges or 140 minutes of “ON time” with a fully charged device.

Phase 2

Phase 1Tilt I1 I4–( )

I1------------------------=

I1

I4

A-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions

Specifications

User Interface

Shock Charge Time: Charge times with a fully charged device:

200 joules in less than 9 seconds


Charge time after 15 discharges delivered from a fully charged device:


System Recharge Times:

Recharge times with a fully discharged device:

Able to deliver 6 shocks or provide 42 minutes of operating time after 24 hours of recharge and 20 shocks or 140 minutes of operating time after 72 hours of recharge time with a new CHARGE-PAK at temperatures above 15°C (59°F).

Controls: LID RELEASE/ON-OFF button—Controls device power.

SHOCK button (semiautomatic version)—Delivers defibrillation energy.

After electrodes are attached to a victim, an automatic version of the device delivers a shock, if appropriate, not requiring operator intervention.

Electrical Protection: Input protected against high voltage defibrillator pulses per IEC60601-1/EN60601-1. See Figure A-2.

Figure A-2 Defibrillation-protected, Type BF Victim Connection

Safety Classification: Internally powered equipment. IEC60601-1/EN60601-1.

User Interface: The user interface includes voice instructions, audible tones, and graphical prompts.

Readiness Display The readiness display shows the device status.

OK Indicator: Indicates OK when the last self test was completed successfully. When the OK indicator is visible, all other indicators are not visible.

The OK indicator is not displayed during device operation.

CHARGE-PAK Indicator:

When displayed, replace the CHARGE-PAK battery charger.

Attention Indicator: When first displayed, at least 6 discharges or 42 minutes of operating time will remain.

Service Indicator: Service required when displayed.


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Specifications

Environmental

Note: All performance specifications defined assume that the unit has been stored (two hours minimum) at the operating temperature prior to operation.

Physical Characteristics

Accessories

CHARGE-PAK Battery Charger

Operating Temperature: 0 to 50° C (32 to 122° F)

Storage Temperature: -40 to 70° C (-40 to 158° F) with CHARGE-PAK and electrodes, maximum exposure time limited to one week.

Atmospheric Pressure: 760 mmHg to 429 mmHg, 0 to 15,000 feet above sea level.

Relative Humidity: 5 to 95% (non-condensing)

Water Resistance: IEC60529/EN60529 IPX4 “Splash proof” with electrodes connected and CHARGE-PAK installed.

Shock: MIL-STD-810E, Method 516.4, Procedure 1, (40g, 6 to 9 msec pulse, ½ sine each axis).

Vibration: MIL-STD-810E, Method 514.4, Helicopter – category 6 (3.75 g rms) and Ground Mobile – category 8 (2.85 g rms).

EMC: Refer to Appendix D for EMC information as defined in IEC 60601-1-2.

Height: 10.7 cm (4.2 in)

Width: 20.3 cm (8.0 in)

Depth: 24.1 cm (9.5 in), excluding handle

Weight: 2.0 kg (4.5 lb) with CHARGE-PAK and electrodes

Type: Li/SO2Cl2 Lithium Sulfuryl Chloride, 11.7V, 1.4 amp-hours.

Replacement: Replace after each use or when CHARGE-PAK indicator is visible (typically after 2 years)

Weight: 80.5 grams (0.18 lb)


Specifications

QUIK-PAK Electrode Pads

Data Storage

Pads: Pacing/defibrillation/ECG electrodes.

Pads Packaging: User-intuitive, rapid-release QUIK-PAK electrodes allow the electrode pads to be pre-connected to the device and protected under a top cover.

Pads Shelf Life: Two years typical.

Electrode Shape: Oval-rectangular.

Electrode Size: 11.2 cm (4.4 in) × 18.5 cm (7.3 in)

Lead Wire: 1.067 meters (3.5 feet)

Conductive Adhesive Gel Contact Area: 82 cm2 (12.8 in2)

Maximum Adhesion Time: 24 hours

Maximum ECG Monitoring Time: 24 hours

Maximum Number of Defibrillation Pulses: 50 at 360 joules

Maximum Pacing Duration: Up to 12 hours

ECG is received from disposable defibrillation electrodes, standard placement (anterior-lateral), or anterior/posterior placement.

Memory Type: Internal digital memory.

ECG Storage: Dual victim Data Storage.

Minimum 20 minutes of ECG stored for the current victim.

Summarized data stored for the previous victim.

Report Types: Continuous ECG—A continuous ECG report for the victim.

Summary—A summary of critical resuscitation events and ECG waveform segments associated with these events.

Event Log report—A report of time stamped markers, which reflect operator and device activity.

Test Log report—A device self test activity report.

Capacity: Minimum 200 time stamped Event Log markers.

Communications: Wireless transfer to a personal computer.

Data Review: Medtronic provides an array of tools to meet customer needs for data viewing and analysis.


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Specifications

CLINICAL SUMMARY: DEFIBRILLATION OF VENTRICULAR FIBRILLATION AND VENTRICULAR TACHYCARDIA

BackgroundMedtronic conducted a multi-centered, prospective, randomized and blinded clinical trial of biphasic truncated exponential (BTE) shocks and conventional monophasic damped sine wave (MDS) shocks. Specifically, the equivalence of 200 J and 130 J BTE shocks to 200 J MDS shocks1 was tested.

MethodsVentricular fibrillation (VF) was induced in 115 patients during evaluation of implantable cardioverter defibrillator function and 39 patients during electrophysiologic evaluation of ventricular arrhythmias. After 19±10 seconds of VF, a customized defibrillator delivered an automatically randomized shock. Efficacy was based on success of this shock. To demonstrate equivalence of test shocks to control shocks, the 95% upper confidence limit of the difference in efficacy (95UCLD), control minus test, was required to be less than 10%.

Results

Ventricular Fibrillation

The efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks (95UCLD=2%). The difference is success rates of 200 J MDS minus 200 J BTE shocks was -10% (exact 95% confidence interval from -27% to 4%). The 130 J BTE shocks were not demonstrated equivalent to 200 J MDS shocks (95UCLD=22%). However, neither was their efficacy significantly lower than that of the 200 J MDS shocks (statistical power limited by small sample sizes). For all shock types, hemodynamic parameters (oxygen saturation and systolic and diastolic blood pressure) were at or near their pre-induction levels by 30 seconds after successful shocks.

Ventricular Tachycardia

Seventy-two episodes of ventricular tachycardia (VT), induced in 62 patients, were treated with randomized shocks. High rates of conversion were observed with biphasic and monophasic shocks. Sample sizes were too small to statistically determine the relationship between success rates of the waveforms tested.

1 S.L. Higgins et al., “A comparison of biphasic and monophasic shocks for external defibrillation,” Prehospital Emergency Care, 2000, 4(4):305-13.

ShockVentricular Fibrillation 1st Shock Success

Exact 95% Confidence Interval

200 J MDS 61/68 (90%) 80 to 96%

200 J BTE 39/39 (100%) 91 to 100%

130 J BTE 39/47 (83%) 69 to 92%


Specifications

Conclusions

In this double-blinded study, the efficacy of the 200 J BTE shocks was demonstrated to be at least equivalent to the efficacy of 200 J MDS shocks for defibrillation of short duration, electrically-induced VF. However, the comparison of efficacy of 130 J biphasic and 200 J monophasic shocks for VF was inconclusive. All waveforms tested provided a high rate of termination of VT. The VT sample sizes were too small to statistically determine the relationship between VT success rates of the waveforms tested.

Compared to conventional shocks for VF, we found no positive or negative effect of biphasic shocks for VF on hemodynamic parameters following the defibrillating shock. It is possible that, compared to 200 J monophasic shocks, 200 J biphasic shocks will in some cases enable earlier termination of VF. Therefore, we conclude that biphasic shocks for VF delivered at conventional energy levels have the potential to improve outcome in resuscitation of victims with sudden cardiac arrest.

ShockVentricular Fibrillation 1st Shock Success

Exact 95% Confidence Interval

200 J MDS 26/28 (93%) 77 to 99%

200 J BTE 22/23 (96%) 78 to 100%

130 J MDS 20/21 (95%) 77 to 100%


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APPENDIX B

SHOCK ADVISORY SYSTEM B

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions B-1© 2006 Medtronic Emergency Response Systems, Inc.

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Shock Advisory System

OVERVIEW OF THE SHOCK ADVISORY SYSTEM

The Shock Advisory System (SAS) is an ECG analysis system built into the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators that advises the operator if it detects a shockable or nonshockable rhythm. This system makes it possible for individuals not trained to interpret ECG rhythms to provide potentially-lifesaving therapy to victims of ventricular fibrillation or pulseless ventricular tachycardia. The SAS contains the following features:

• Electrode contact determination

• Automated interpretation of the ECG

• Operator control of shock therapy

• Motion detection

Electrode Contact DeterminationThe victim's transthoracic impedance is measured through the defibrillation electrodes. If the baseline impedance is higher than a maximum limit, it is determined that the electrodes are not in sufficient contact with the victim or not properly connected to the defibrillator. ECG analysis and shock delivery are inhibited. The operator is advised to connect electrodes any time electrode contact is inadequate.

Automated Interpretation of the ECGThe Shock Advisory System is designed to recommend a shock if it detects the following:

• Ventricular fibrillation — with a peak-to-peak amplitude of at least 0.08 mV

• Ventricular tachycardia — defined as having a heart rate of at least 120 beats per minute, QRS width of at least 0.16 seconds, and no apparent P waves.

Pacemaker pulses may prevent advisement of an appropriate shock, regardless of the victim’s underlying rhythm. The SAS is designed to recommend no shock for all other ECG rhythms including pulseless electrical activity, idioventricular rhythms, bradycardia, supraventricular tachycardias, and normal sinus rhythms.

ECG analysis is performed on consecutive 2.7 second segments of ECG. The analysis of two out of three segments must agree before a decision (SHOCK ADVISED or NO SHOCK ADVISED) is made.

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillator SAS performance for adult, pacemaker and pediatric ECGs is summarized in the following table.

Table B-1 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Adult ECGs

Rhythm Class ECG Test1 Sample Size

Performance Goal2, 3Observed PerformanceSensitivity or Specificity [LCL]4

Shockable: coarse VF

168 >90% sensitivity 100.0% [98.6%]

Shockable: shockable VT

65 >75% sensitivity 84.6% [77.3%]

Nonshockable: NSR

144 >99% specificity for NSR (AHA)

100.0% [98.4%]

Nonshockable: asystole

43 >95% specificity 100.0% [94.8%]

B-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions


The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators were also tested using paced rhythms recorded at high-fidelity from victims with implanted pacemakers. The high-fidelity pacemaker spikes were also added to samples of ventricular fibrillation to test the defibrillator’s ability to reach a shock decision in the case of ventricular fibrillation with an implanted, active pacemaker. The results are summarized in the following table.

Table B-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance with Active Pacemakers

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators were also tested using ECGs acquired from hospitalized pediatric victims ranging in age from < 1 day old to 17 years old. The results are summarized in the following table.

Nonshockable: all other rhythms

531 >95% specificity 95.9% [94.5%]

Intermediate: fine VF

29 Report only 96.6% [87.2%] sensitivity

1 From Medtronic ECG database. Each sample is run 10 times asynchronously.2 Association for the Advancement of Medical Instrumentation. DF39-1993 Standard for Automatic External Defibrillators and Remote-Control Defibrillators. Arlington, VA: AAMI;1993.

3 Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. AHA Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997, Vol. 95, 1677-1682.

4 LCL = 90% exact one-sided lower confidence limit

VF = ventricular fibrillation

VT= ventricular tachycardia

NSR = normal sinus rhythm

Rhythm ClassECG TestSample Size

Performance Goal Observed Performance

Shockable: Coarse VF

35 >90% sensitivity 91.4% [81.9%]

Nonshockable:Paced rhythms

35 >95% specificity 100.0% [93.6%]

Table B-3 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Pediatric ECGs

Rhythm Class ECG Test1

Sample SizePerformance Goal2

Observed PerformanceSensitivity or Specificity [LCL]3

Shockable: coarse VF

90 >90% sensitivity 100.0% [97.5%]

Shockable: shockable VT

11 >75% sensitivity 54.5% [31.8%]

Nonshockable: NSR

424 >99% specificity 100.0% [99.5%]

Nonshockable: asystole

95 >95% specificity 100.0% [97.6%]

Table B-1 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Adult ECGs (Continued)

Rhythm Class ECG Test1 Sample Size

Performance Goal2, 3Observed PerformanceSensitivity or Specificity [LCL]4

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions B-3© 2006 Medtronic Emergency Response Systems, Inc.

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Control of Shock TherapyThe Shock Advisory System causes the defibrillator to charge automatically when it detects the presence of a shockable rhythm. When a shockable rhythm is detected, the defibrillator automatically delivers a shock or instructs the user to deliver the shock by pressing the shock button.

Motion DetectionThe Shock Advisory System detects victim motion independent of ECG analysis. A motion detector is designed into the defibrillator. MOTION DETECTION can be configured to be ON or OFF.

A number of activities can create motion, including CPR, rescuer movement, patient movement, vehicle movement, and some internal pacemakers. If variations in the transthoracic impedance signal exceed a maximum limit, the Shock Advisory System determines that patient motion of some kind is present. If motion is detected, the ECG analysis is inhibited. The operator is advised by a displayed message, a voice prompt, and an audible alert. After 10 seconds, if motion is still present, the motion alert stops and the analysis always proceeds to completion. This limits the delay in therapy in situations where it may not be possible to stop the motion. However, the rescuer should remove the source of motion whenever possible to minimize the chance of artifact in the ECG.

There are two reasons why ECG analysis is inhibited when the motion alert occurs, and why the rescuer should remove the source of the motion whenever possible:

• Such motion may cause artifact in the ECG signal. This artifact may occasionally cause the Shock Advisory System to reach an incorrect decision.

• The motion may be caused by a rescuer's interventions. To reduce the risk of inadvertently shocking a rescuer, the motion alert prompts the rescuer to move away from the patient. This will stop the motion and ECG analysis will proceed.

Nonshockable: all other rhythms

433 >95% specificity 99.3% [98.5%]

Intermediate: fine VF

4 Report only 100.0% [56.2%] sensitivity

Intermediate: other VT

7 Report only 42.9% [17.0%] specificity

1 From Medtronic ECG database.2 Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. AHA Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Circulation, 1997, Vol. 95, 1677-1682.

3 LCL = 90% exact one-sided lower confidence limit.

Table B-3 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator SAS Performance Table for Pediatric ECGs (Continued)

Rhythm Class ECG Test1

Sample SizePerformance Goal2

Observed PerformanceSensitivity or Specificity [LCL]3


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APPENDIX C

USER’S CHECKLIST C

This User’s Checklist may be reproduced.

LIFEPAK CR® PLUS LIFEPAK EXPRESS® DEFIBRILLATORUSER’S CHECKLIST

Unit Serial Number ________________________

Department/Location _______________________

InstructionRecommended

Corrective Action

Date

Initials

1 Check readiness display for:

OK indicator None.

CHARGE-PAK indicator Replace CHARGE-PAK™ Battery Charger and QUIK-PAK™ Electrode Packet.

ATTENTION indicator Refer to operating instructions.

WRENCH indicator Contact authorized service personnel.

2 Check Use By date on all Electrode Packets.

Replace electrode packet and CHARGE-PAK if date passed.

3 Check additional supplies. Replenish as needed.

4 Check defibrillator for:

Damage or cracks Contact authorized service personnel.

Foreign substances Clean the device.

5 Other:


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DAPPENDIX D

DECLARATION OF CONFORMITY/ELECTROMAGNETIC COMPATIBILITY GUIDANCE D

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions D-1© 2006 Medtronic Emergency Response Systems, Inc.

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Declaration of Conformity/Electromagnetic Compatibility Guidance

* See EMC tables

EC DECLARATION OF CONFORMITY

Manufacturer’s Name: Medtronic Emergency Response Systems, Inc.

Manufacturer’s Address: 11811 Willows Road NERedmond, WA 98052-2003 USA

declares that the CE-marked product

Product Name: LIFEPAK CR® Plus defibrillator

Part Number(s): 3200731

complies with 93/42/EEC (Medical Device Directive) class IIb. Conformity assessed per Annex II.

This product complies with:

Safety: EN 60601-1:1996

Internally powered, Type BF, Continuous operation

IEC 60601-2-4:1983

EMC: EN 60601-1-2: 2001

EN 60601-2-4:2003

CISPR11 (Amd. A1:2004):2003 Class B, Group 1

EN 61000-4-2:2001 8kV CD, 15kV AD

EN 61000-4-3:2002 10 V/m (20 V/m EN 60601-2-4)*

IEC 61000-4-8:2001 3A/m

Supplementary Information

Included are the following accessories and interconnecting cables:

QUIK-PAK™ electrode set, MIN 3200727

Lithium CHARGE-PAK™, MIN 3200730

Replacement kit, MIN 3201616

Infant/Child Reduced Energy Defibrillation Electrodes, MIN 3202380

This product also complies with: UL 2601-1:1994,

CSA C22.2 No. 601.1 and CSA C22.2 No. 601.2.4

Redmond, November 7, 2005

James W. Dennison

Vice President, Quality and Regulatory Affairs

This declaration applies to CE marked devices produced after the date of issuance of this declaration and before it is either superseded by another declaration or withdrawn.

Authorized EC Representative: Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands

D-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions


* See EMC tables

EC DECLARATION OF CONFORMITY

Manufacturer’s Name: Medtronic Emergency Response Systems, Inc.

Manufacturer’s Address: 11811 Willows Road NERedmond, WA 98052-2003 USA

declares that the CE-marked product

Product Name: LIFEPAK EXPRESS® defibrillator

Part Number(s): 3202177

complies with 93/42/EEC (Medical Device Directive) class IIb. Conformity assessed per Annex II.This product complies with:

Safety: EN 60601-1:1996

Internally powered, Type BF, Continuous operation

IEC 60601-2-4:1983

EMC: EN 60601-1-2:2001

EN 60601-2-4:2003

CISPR11 (Amd. A1:2004):2003 Class B, Group 1

EN 61000-4-2:2001 8kV CD, 15kV AD

EN 61000-4-3:2002 10 V/m (20V/m EN 60601-2-4)*

IEC 61000-4-8:2001 3A/m

Supplementary InformationIncluded are the following accessories and interconnecting cables:

QUIK-PAK™ electrode set, MIN 3200727

Lithium CHARGE-PAK™, MIN 3200730

Replacement kit, MIN 3201616

Infant/Child Reduced Energy Defibrillation Electrodes, MIN 3202380

This product also compiles with: UL 2601-1:1994

CSA C22.2 No. 601.1 and CSA C22.2 No. 601.2.4

Redmond, November 7, 2005

James W. DennisonVice President, Quality and Regulatory Affairs

This declaration applies to CE marked devices produced after the date of issuance of this declaration and before it is either superseded by another declaration or withdrawn.

Authorized EC Representative: Medtronic B.V., Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands


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Essential PerformanceThe LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators maintain safe and effective performance of the defibrillation therapy and patient monitoring functions when operated in the electromagnetic environment specified in Tables 2 through 4.

Limitations Affecting Immunity to Electromagnetic DisturbancesThe level of protection from electromagnetic disturbances is limited by several factors, including requirements for protection from third-party defibrillators, patient safety isolation, and maintenance of adequate signal-to-noise ratios for processing patient signals.

Table D-1 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in the electromagnetic environment specified below. The customer or the user of the defibrillator should ensure that the defibrillator is used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions

CISPR 11

Group 1 The defibrillator uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions

CISPR 11

Class B The defibrillator is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic emissions

IEC 61000-3-2

Not Applicable

Voltage fluctuations/flicker emissions

IEC 61000-3-3

Not Applicable



Table D-2 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity


Immunity TestIEC 60601 Test Level

Compliance LevelElectromagnetic Environment –

Guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

±6 kV contact

±8 kV air

±8 kV contact

±15 kV air

The defibrillator is suitable for use in a dry environment.

Electrical fast transient/burst

IEC 61000-4-4

±2 kV for power supply lines

±1 kV for input/output lines

Not Applicable Not Applicable

Surge

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode


Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5 % UT

(>95% dip in UT)for 0.5 cycle

40% UT

(60% dip in UT)for 5 cycles

70% UT

(30% dip in UT)for 25 cycles

<5 % UT

(>95% dip in UT)for 5 s


Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note: UT is the a.c. mains voltage prior to application of the test level.


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Table D-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

Immunity TestIEC 60601 Test Level

Compliance Level Electromagnetic Environment – Guidance


Portable and mobile RF communications equipment should be used no closer to any part of the defibrillator, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF

IEC 61000-4-6

3 Vrms

150 kHz to 80 MHz outside ISM bands*

* The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.


10 Vrms

150 kHz to 80 MHz in ISM bandsa


Radiated RF

IEC 61000-4-3

10 V/m

80 MHz to 2.5 GHz

10 V/m

80 MHz to 870 MHz,900 MHz to 2.5 GHz

d = 1.2√ P 80 MHz to 800 MHz

d = 2.3√ P for specified frequencies in the range 800 MHz to 2.5 GHz

3 V/m

870 MHz to 900 MHz

d = 7.7√ P 870 MHz to 900 MHz

Where P is the maximum output power rating of the transmitter in watts (w) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).†

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,‡ should be less than the compliance level in each frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

† The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

‡ Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitter, an electromagnetic site survey should be considered. If the measured field strength in the location in which the defibrillator is used exceeds the applicable RF compliance level above, the defibrillator should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the defibrillator.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.



Table D-4 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators

Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators

The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the defibrillator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the defibrillator as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitterW

Separation distance according to frequency of transmitterm

150 kHz to 80 MHz 80 MHz to 800 MHz

d = 1.2√ P

80 MHz to 870 MHz,900 MHz to 2.5 GHz

d = 2.3√ P

870 MHz to 900 GHz

d = 7.7√ P

0.01 Not Applicable 0.12 0.23 0.77

0.1 Not Applicable 0.38 0.73 2.43

1 Not Applicable 1.2 2.3 7.7

10 Not Applicable 3.8 7.3 24.3

100 Not Applicable 12 23 77

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.

Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.

Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions Index-1© 2006 Medtronic Emergency Response Systems, Inc.

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ex

INDEX

AAbout Automatic External

Defibrillators 1-2About the Defibrillators 1-8Accessories 5-7ADAPTIV 1-9AED 1-2, 1-3Attention Indicator 2-4, 5-2

BBasic Steps 3-3Blue Plastic 2-6, 2-7

CCardiac Arrest 1-3Caring for the Defibrillator 5-1Carrying Handle 2-4, 2-5CHARGE-PAK 1-9, 2-4, 2-5CHARGE-PAK Indicator 2-4, 5-2Cleaning Methods 5-2Cleaning the Defibrillator 5-2Clinical Summary A-5Continuous ECG 4-2Controls 2-4CPR 1-3CPR Time 6-3

DData Storage 4-2Data Storage Characteristics A-4Data Stored by the

Defibrillator 4-2Data Transfer

Current Record 4-2Deleting Data 4-2Previous Record 4-2Storing Data 4-2

Defibrillation 1-2, 1-3Defibrillator

Operator SettingsMotion Detection 6-4

Device Identification 6-2Disconnecting Electrode

Pads 3-5

EECG 1-3Electrode Connector 2-6, 2-7Electrode Indicators 2-6, 2-7Electrode Packet 2-5, 2-6Electrode Packet Anchor Pin 2-5,

2-6Electrode Packet Release

Handle 2-5, 2-6Electrode Pad

Recycling/Disposal 5-7Electrode Pads 2-6, 2-7Energy Protocol 6-2Energy Sequence

Energy Levels 6-2Environmental Specifications A-3Event and Test Log 4-3Event and Test Log Reports 4-3Event Log 4-2

FFibrillation 1-3

GGetting Started 2-1

HHeart Attack 1-3

IImpedance 1-3Indications for Use 1-2Indicators 2-4Inside Features 2-5, 2-6Inspecting the Defibrillator 2-4IrDA Port 1-9, 2-4, 2-5

JJoule 1-3

LLabels 2-4LED 1-3Lid 2-4LIFEPAK Defibrillator

Accessories 1-9Automated Operation

Fully Automatic 1-9Semiautomatic 1-9

Automatic Self-Test 1-9Capabilities and

Features 1-9

Index-2 LIFEPAK CR Plus and LIFEPAK EXPRESS Defibrillator Operating Instructions

Index

Customized Setup 1-9Data Management 1-9Defibrillation Electrodes 1-9Defibrillation Waveform 1-9Heart Rhythm Analysis 1-9Operator Settings

Motion Detection 1-10Power System 1-10Readiness Display 1-10Troubleshooting 3-6

Log Reports 4-3

MMaintaining a State of

Readiness 5-2Managing Data 4-1Motion Detected 3-6Motion Detection 6-4Myocardial Infarction 1-3

NNonshockable Rhythm 1-3

OObtaining Authorized Service 5-7OK Indicator 2-4, 5-2ON-OFF Button 2-4Opening the Electrode

Packet 3-3Operating Settings 6-2

About 6-1Operating Settings and Setup

Configuration 6-2Operator Settings

CPR Time Settings 6-3Device Date 6-3Device ID 6-2Device Time 6-3Energy Protocol 6-2Energy Sequence 6-2Pulse Check 6-3Pulse Prompt 6-3Stack Shocks 6-3Time Zone 6-4Voice Prompt Volume 6-3

Outside Controls Indicators and Labels 2-4

Overview of Data Storage 4-2

PPhysical Characteristics A-3Placing Electrode Pads 3-3, 3-4,

3-6Problem Conditions 3-6Pulse Check 6-3Pulse Prompt 6-3

QQuick Reference Card 2-5, 2-6QUIK-PAK Electrodes 1-9

RReadiness Display 2-4Readiness Display,

Troubleshooting 3-6Recycling Information 5-7Regular Maintenance 5-2Reports Stored 4-2Responder 1-3Responding to a Sudden Cardiac

Arrest Victim 3-2

SSafety Information 1-4Safety Terms 1-4Safety Warnings 2-4, 2-5SAS 1-3Serial Number Label 2-4, 2-5Service 5-7Shock Advisory System B-1Shock Button 2-6, 2-7Shockable Rhythm 1-3Speaker 2-6, 2-7Specifications A-1Stack Shocks 6-3Summary 4-2Supplies 5-7Symbols 1-6

TTerminology 1-3Test and Service Data 4-2Text Conventions 1-4Time Zone 6-4Training Tools 5-7Treating a Victim 3-3Troubleshooting 3-6Troubleshooting During Victim

Use 3-6

UUnpacking and Inspecting 2-2Use By Date 2-5, 2-6User 1-3User Interface Specifications A-2Using the Defibrillator 3-1, 3-3

VVentricular Fibrillation 1-2, 1-3Ventricular Tachycardia 1-3Victim 1-3Victim Care

Transferring 3-5Treating the Victim 3-2Troubleshooting 3-6

Voice Prompt Volume 6-3Voice Prompts and Tones 3-5

Voice Prompts, Troubleshooting 3-6

WWarnings and Cautions 1-4, 3-2

General 1-4Warranty Information 5-7What to Do After Emergency

Medical Personnel Arrive 3-5

What to Do After Using the Defibrillator 3-5

Where to locate your Defibrillator 2-3

Why the Need for Defibrillators 1-2

Wrench Indicator 2-4, 5-2

Device Tracking

The U.S. Food and Drug Administration classifies defibrillators as a medical device that requires tracking (knowing where the device is located). As such, federal regulations require that manufacturers maintain tracking information for each device distributed. We rely on our customers to provide accurate device location information. This tracking information provides the manufacturer the ability to locate the device and perform a product correction, should it ever be needed.

Tracking information must specify the physical location of the device, not just the headquarters or receiving department’s shipping address. The tracking information required is:

1 Customer name and department name

2 Physical address (actual physical location, for example, 123 Main Street, Third Floor, Suite A)

3 City, State, and Zip Code

4 A contact name and telephone number

5 Device part number and serial number

The address to which this particular device was shipped is the current tracking location. If this device is located somewhere other than the shipping address, or if you have purchased this device from someone other than Medtronic, please either call our device tracking coordinator at 1.800.426.4448, or use one of the postage-paid address change cards below to update this vital information.

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Medtronic Emergency Response Systems11811 Willows Road Northeast Redmond, WA 98052-2003 USATelephone: 425.867.4000Toll Free (USA only): 888 351.LIFE (5433)Fax: 425.867.4121Internet: www.medtronic-ers.com

www.medtronic.com

Medtronic Europe S.A.Medtronic Emergency Response SystemsRte. du Molliau 31Case postale 841131 TolochenazSwitzerlandTelephone: 41.21.802.7000Fax: 41.21.802.7900

MIN 3201686-010 / CAT 26500-001361

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